The GRT LITE Model PRO-8 A is substantially equivalent to other pulsed therapeutic light therapy systems currently in commercial distribution. The Model PRO-8A has the same intended use and similar technological characteristics to predicate devices. It combines the clinically accepted therapeutic uses of several previously FDA 510(k) approved light therapy systems currently in commercial distribution into one compact system.
The technological equivalence to the predicate devices is substantiated by the wavelength and power output generated by the Model PRO-8A. The Model PRO-8A will provide the same treatment benefits and regimens for clinical presentations already approved by the Food and Drug Administration for the predicate devices.
The predicate devices the Model PRO-8A establishes equivalence to include:
Predicate Device510(k) ifManufacturerTuco Erchonia PL3000KO 12580Tuco InnovationsExcalibur SystemK041530Stargate International, Inc.Microlight 830 LaserK010175Microlight Corporation of AmericaAcculaser Pro LLLTK020657Acculaser, Inc.Device
The GRT LITE Model PRO-8A is a non-heating lamp, infrared as described under the provisions of 21CFR §890.5500 and is clinically indicated for:
Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of nisculoskeletal origin.
Adjunctive use in providing temporary relief of minor chronic pain associated with Carpal Tunnel Syndrome (CTS).
As with the predicate devices, pain therapy treatment can be prescribed for pain associated with the clinical presentations specified above by having the beams pulsed or continuous with time considerations. The GRT LITE Model PRO-8A's variables conform to the performance specifications of the clinical parameters used by the predicate devices in wavelength, frequency as a function of time, and power output.